United States· US:0713-0132_0b625ebc-4f41-49d9-e063-6294a90a56ef

PROMETHEGAN

A medicinal product containing promethazine hydrochloride, registered in United States by Cosette Pharmaceuticals, Inc..

US label

Checked against FDA National Drug Code directory (United States) on September 27, 2026

Informational only — not a medical device.

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The record

At a glance

FDA National Drug Code directory (United States)

Active substance: PROMETHAZINE HYDROCHLORIDE
Manufacturer: Cosette Pharmaceuticals, Inc.
Country: United States (US)
ATC code: —
Reimbursed: Not published by this register
Source register: FDA National Drug Code directory (United States)
Last checked: September 27, 2026

Packs & prices · 4

ndc11
0713013210
1000 SUPPOSITORY in 1 BOX (0713-0132-10)
ndc11
0713013212
12 SUPPOSITORY in 1 BOX (0713-0132-12)
ndc11
0713-0132-10
ndc11
0713-0132-12

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Promethazine hydrochloride in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All promethazine hydrochloride products

Authorised across Europe · EMA

The same active substance is authorised in 20 EEA countries. Names it is sold under:

Bulgaria · Aнтиалeрзин
Cyprus · Promethazine Remedica
Czechia · Prothazin
Germany · Atosil, Atosil N
Denmark · Phenergan, Prometazin Actavis
Spain · Fenergan
France · Phenergan
United Kingdom (Northern Ireland) · Phenergan, Phenergan Elixir
Greece · Fenimezyl, Prugal-Derm
Hungary · Pipolphen
Ireland · Phenergan
Iceland · Phenergan, Prometazin Actavis
Italy · Alontan Antistaminico, Fadezin
Malta · Fenazil, Promethazine Remedica
Netherlands · Promethazine Ace, Promethazine Cf
Norway · Phenergan
Poland · Diphergan, Polfergan
Portugal · Prometazina Basi, Prometazina Medlink
Sweden · Farghess, Lergigan
Slovakia · Prothazin

Source: European Medicines Agency, Article 57 product data.

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload

GET /v1/drugs/28557d95-04b3-4178-8f13-95026e196df6
GET /v1/drugs/28557d95-04b3-4178-8f13-95026e196df6?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "RECTAL",
  "source": "ndc",
  "strength": "50",
  "substance": "PROMETHAZINE HYDROCHLORIDE",
  "productndc": "0713-0132",
  "dosage_form": "SUPPOSITORY",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA087165",
  "marketing_category": "ANDA"
}

API reference MCP server Plans

See everything about promethazine hydrochloride.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.

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